Phase
Condition
Amyloidosis
Treatment
Daratumumab
Dexamethasone, 40 mg
Bortezomib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histopathological diagnosis of amyloidosis based on detection byimmunohistochemistry and polarizing light microscopy of green bi-refringent materialin congo red stained tissue specimens (in an organ other than bone marrow) orcharacteristic electron microscopy appearance
Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at leastone of the following:
serum monoclonal (M)-protein greater than or equal (>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis andimmunofixation [IFE] performed at a central laboratory)
serum free light chain greater than or equal to (>=) 50 milligram/Liter (mg/L)with an abnormal kappa:lambda ratio or the difference between involved anduninvolved free light chains (dFLC) >= 50 mg/L
One or more organs impacted by AL amyloidosis according to consensus guidelines
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
Exclusion
Exclusion Criteria:
Prior therapy for AL amyloidosis or multiple myeloma including medications thattarget CD38, with the exception of 160 mg dexamethasone (or equivalentcorticosteroid) maximum exposure prior to randomization
Previous or current diagnosis of symptomatic multiple myeloma, including thepresence of lytic bone disease, plasmacytomas, >= 60 percent (%) plasma cells in thebone marrow, or hypercalcemia
Evidence of significant cardiovascular conditions as specified below:
NT-ProBNP > 8500 nanogram per liter (ng/L)
New York Heart Association (NYHA) classification IIIB or IV heart failure
Heart failure that in the opinion of the investigator is on the basis ofischemic heart disease (eg, prior myocardial infarction with documented historyof cardiac enzyme elevation and electrocardiogram [ECG] changes) or uncorrectedvalvular disease and not primarily due to AL amyloid cardiomyopathy
Inpatient admission to a hospital for unstable angina or myocardial infarctionwithin the last 6 months prior to first dose or percutaneous cardiacintervention with recent stent within 6 months or coronary artery bypassgrafting within 6 months
For participants with congestive heart failure, cardiovascular-relatedhospitalizations within 4 weeks prior to randomization
Participants with a history of sustained ventricular tachycardia or abortedventricular fibrillation or with a history of atrioventricular (AV) nodal orsinoatrial (SA) nodal dysfunction for which a pacemaker/implantablecardioverter-defibrillators [ICD] is indicated but not placed (participants whodo have a pacemaker/ICD are allowed on study)
Screening 12-lead ECG showing a baseline QT interval as corrected byFridericia's formula (QTcF) > 500 milliseconds (msec). Participants who have apacemaker may be included regardless of calculated QTc interval
Supine systolic blood pressure < 90 millimeter of mercury (mmHg), orsymptomatic orthostatic hypotension, defined as a decrease in systolic bloodpressure upon standing of > 20 mmHg despite medical management (eg, midodrine,fludrocortisones) in the absence of volume depletion
Planned stem cell transplant during the first 6 cycles of protocol therapy areexcluded. Stem cell collection during the first 6 cycles of protocol therapy ispermitted
Known to be seropositive for human immunodeficiency virus (HIV)
Any one of the following:
Seropositive for hepatitis B (defined by a positive test for hepatitis Bsurface antigen [HBsAg]). Participants with resolved infection (ie,participants who are HBsAg negative but positive for antibodies to hepatitis Bcore antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR)measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels.Those who are PCR positive will be excluded
Known to be seropositive for hepatitis C (except in the setting of a sustainedvirologic response [SVR], defined as aviremia at least 12 weeks aftercompletion of antiviral therapy)
- Grade 2 sensory or Grade 1 painful peripheral neuropathy
Study Design
Study Description
Connect with a study center
Box Hill Hospital
Box Hill, 3128
AustraliaSite Not Available
Sir Charles Gairdner Hospital
Nedlands, 6009
AustraliaSite Not Available
Westmead Hospital
Westmead, 2145
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, 4102
AustraliaSite Not Available
Institut Jules Bordet
Anderlecht, 1070
BelgiumSite Not Available
Institut Jules Bordet
Brussel, 1000
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
Virga Jessa Ziekenhuis
Hasselt, 3500
BelgiumSite Not Available
Az Groeninge
Kortrijk, 8500
BelgiumSite Not Available
Universitair Ziekenhuis Leuven
Leuven, 3000
BelgiumSite Not Available
AZ Nikolaas
Sint-Niklaas, 9100
BelgiumSite Not Available
AZ Turnhout
Turnhout, 2300
BelgiumSite Not Available
UCL Mont Godinne
Yvoir, 5530
BelgiumSite Not Available
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Sociedade Pernambucana de Combate ao Cancer
Recife, 50040-000
BrazilSite Not Available
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775 001
BrazilSite Not Available
Hospital Sao Rafael
Salvador, 41253 190
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
Sao Jose do Rio Preto, 15090-000
BrazilSite Not Available
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
Sao Paulo, 04039-004
BrazilSite Not Available
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
Sao Paulo, 04039-004
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
São José do Rio Preto, 15090-000
BrazilSite Not Available
Clinica Sao Germano
São Paulo, 01455 010
BrazilSite Not Available
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403-010
BrazilSite Not Available
Alberta Health Services
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
CanadaSite Not Available
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
CanadaSite Not Available
Alberta Health Services
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
London Health Sciences Center
London, Ontario N6A 5W9
CanadaSite Not Available
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
University Health Network UHN Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
Peking University People s Hospital
Beijing, 100044
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, 350000
ChinaSite Not Available
First affiliated Hospital of Zhejiang University
Hangzhou, 310020
ChinaSite Not Available
Nanjing General Hospital
Nanjing, 210002
ChinaSite Not Available
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, 200025
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
ChinaSite Not Available
Aarhus University Hospital
Aarhus C, 8000
DenmarkSite Not Available
Aarhus University Hospital
Aarhus N, DK-8200
DenmarkSite Not Available
Dep. of Hematology, Rigshospitalet
Copenhagen, 2400
DenmarkSite Not Available
Odense Universitets Hospital
Odense, 5000
DenmarkSite Not Available
CHU Dijon
Dijon, 21000
FranceSite Not Available
Hopital Claude Huriez
Lille cedex, 59037
FranceSite Not Available
CHU de Limoges - Fédération Hépatologie
Limoges, 87000
FranceSite Not Available
Institut Paoli Calmettes
Marseille, 13273
FranceSite Not Available
Chu Hotel Dieu
Nantes cedex 01, 44035
FranceSite Not Available
Hopital Saint Louis
PARIS cedex 10, 75475
FranceSite Not Available
Hopital Saint-Louis
PARIS cedex 10, 75475
FranceSite Not Available
Centre hospitalier Lyon-Sud
Pierre - Bénite cedex, 69495
FranceSite Not Available
CHU De Poitiers
Poitiers, 86000
FranceSite Not Available
CHU Rangueil
Toulouse, 31400
FranceSite Not Available
CHU Bretonneau
Tours cedex, 37044
FranceSite Not Available
CHU de Nancy_ Hopital Brabois
Vandoeuvre les Nancy, 54511
FranceSite Not Available
Charite Campus Benjamin Franklin
Berlin, 12203
GermanySite Not Available
Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden, 1307
GermanySite Not Available
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, 40225
GermanySite Not Available
Universitatsklinikum Essen
Essen, 45122
GermanySite Not Available
HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH
Hamburg, 22767
GermanySite Not Available
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg, 69120
GermanySite Not Available
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, 72076
GermanySite Not Available
Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
Würzburg, 97080
GermanySite Not Available
Alexandra General Hospital of Athens
Athens, 11528
GreeceSite Not Available
University General Hospital of Rio
Patra, 26500
GreeceSite Not Available
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest, 1097
HungarySite Not Available
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
Budapest, 1097
HungarySite Not Available
Semmelweis Egyetem I.Belgyogyaszati Klinika
Budapest, 1088
HungarySite Not Available
Carmel Hospital
Haifa, 34362
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 91120
IsraelSite Not Available
Sheba Medical Center
Ramat-Gan, 52621
IsraelSite Not Available
Sourasky Medical Center
Tel-Aviv, 6423906
IsraelSite Not Available
Assaf Ha'Rofeh Medical Center
Zerifin, 70300
IsraelSite Not Available
Policlinico di Bari
Bari, 70124
ItalySite Not Available
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna, 40138
ItalySite Not Available
Casa di Cura La Maddalena
Palermo, 90146
ItalySite Not Available
Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I
Roma, 00161
ItalySite Not Available
A.O.U. Città della Salute e della Scienza
Torino, 10126
ItalySite Not Available
Fukushima Medical University Hospital
Fukushima, 960 1295
JapanSite Not Available
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619
JapanSite Not Available
Teine Keijinkai Hospital
Hokkaido, 006-8555
JapanSite Not Available
Kanazawa University Hospital
Kanazawa, 920 8641
JapanSite Not Available
Kumamoto University Hospital
Kumamoto-City, 860-8556
JapanSite Not Available
Kyoto Kuramaguchi Medical Center
Kyoto, 603-8151
JapanSite Not Available
Shinshu University Hospital
Matsumoto, 390 8621
JapanSite Not Available
Matsuyama Red Cross Hospital
Matsuyama, 790-8524
JapanSite Not Available
Nagoya City University Hospital
Nagoya, 467 8602
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
JapanSite Not Available
Japanese Red Cross Medical Center
Shibuya, 150-8935
JapanSite Not Available
Tokushima University Hospital
Tokushima, 770-8503
JapanSite Not Available
Pusan National University Hospital
Busan, 49241
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Centro de Investigación Farmacéutica Especializada
Guadalajara, 44160
MexicoSite Not Available
Hospital Regional De Alta Especialidad Ixtapaluca
Ixtapaluca, 56530
MexicoSite Not Available
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Mexico City, 14080
MexicoSite Not Available
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
Monterrey, 64460
MexicoSite Not Available
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
MexicoSite Not Available
Haga ziekenhuis
Den Haag, 2545 AA
NetherlandsSite Not Available
UMCG
Groningen, 9713 GZ
NetherlandsSite Not Available
Erasmus MC
Rotterdam, 3015 CN
NetherlandsSite Not Available
UMC Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
Maxima Medisch Centrum
Veldhoven, 5504 DB
NetherlandsSite Not Available
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow, 41-500
PolandSite Not Available
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, 41-500
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny im. A.Mieleckiego Slaskiego Uniwersytetu Medycznego
Katowice, 40-032
PolandSite Not Available
SKPP UM w Poznaniu
Poznan, 60-569
PolandSite Not Available
Specjalistyczny Szpital Miejski
Torun, 87-100
PolandSite Not Available
Instytut Hematologii i Transfuzjologii
Warszawa, 02 776
PolandSite Not Available
Institut Clinic Fundeni
Bucuresti, 22328
RomaniaSite Not Available
Institutul Regional de Oncologie Iasi
Iasi, 700483
RomaniaSite Not Available
Inst. Cat. D'Oncologia-Badalona
Badalona, 08916
SpainSite Not Available
Hosp Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp. Univ. Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
SpainSite Not Available
Hosp. de Leon
Leon, 24080
SpainSite Not Available
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Hosp. Univ. 12 De Octubre
Madrid, 28041
SpainSite Not Available
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hosp. Univ. Fund. Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainSite Not Available
Clinica Univ. de Navarra
Pamplona, 31008
SpainSite Not Available
Hosp Clinico Univ de Salamanca
Salamanca, 37007
SpainSite Not Available
Hosp. Clinico Univ. de Salamanca
Salamanca, 37007
SpainSite Not Available
Hosp. Univ. de Canarias
San Cristóbal de La Laguna, 38320
SpainSite Not Available
Hosp. Univ. Dr. Peset
Valencia, 46017
SpainSite Not Available
South Elvsborg Hospital
Boras, 501 82
SwedenSite Not Available
Skanes universitetssjukhus
Lund, 221 85
SwedenSite Not Available
Karolinska University Hospital, Huddinge
Stockholm, 141 86
SwedenSite Not Available
Akademiska Sjukhuset
Uppsala, 751 85
SwedenSite Not Available
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06590
TurkeySite Not Available
Akdeniz University Medical Faculty
Antalya, 7059
TurkeySite Not Available
Ondokuz Mayis Universitesi Tip Fakultesi
Atakum, 55270
TurkeySite Not Available
Ondokuz Mayis Universitesi Tip Fakultesiy
Atakum, 55270
TurkeySite Not Available
Trakya University Medical Faculty
Edirne, 22030
TurkeySite Not Available
Gaziantep University School of Medicine
Gaziantep, 27310
TurkeySite Not Available
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
TurkeySite Not Available
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340
TurkeySite Not Available
V.K.V. Amerikan Hastanesi
Sisli, 34365
TurkeySite Not Available
Erciyes University Medical Faculty
Talas, 38039
TurkeySite Not Available
University Hospitals Birmingham NHS Trust,
Birmingham, B15 2TH
United KingdomSite Not Available
University College Hospital
London, NW1 2PG
United KingdomSite Not Available
Mayo Clinic Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Scripps Clinic
La Jolla, California 92037
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94143
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94143
United StatesSite Not Available
Stanford University
Stanford, California 94305
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesSite Not Available
Mayo Clinic
Jacksonville, Florida 32224
United StatesSite Not Available
Winship Cancer Institute Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
Boston University Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215-5418
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215-5418
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School Of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Wake Forest University Health Sciences - Cardiovascular Medicine
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health And Science University
Portland, Oregon 97239
United StatesSite Not Available
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
Seattle Cancer Care Alliance
Seattle, Washington 98109-1023
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.